Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Zenflow Spring System: Minimally Invasive Treatment for LUTS associated with BPH

Study summary

The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.

Eligibility

Primary outcome measure(s)

• Effectiveness - IPSS — Baseline to 12 Months
  The primary effectiveness endpoint is the change in IPSS from baseline over time
• Safety - adverse events — Baseline to 12 Months
  The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)

Trial sites (8)

Other trials for the same condition